Human-tissue-related inventions: Ownership and intellectual property rights in international collaborative research in developing countries

Journal of Medical Ethics

Volumn 34, Issue 3, 2008, Pages 171-179

  Andanda, Pamela A ^a,b  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b UNIVERSITY OF KWAZULU NATAL   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ARTICLE; DEVELOPING COUNTRY; ETHICS; EUROPEAN UNION; FORECASTING; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MANAGEMENT; ORGANIZATION AND MANAGEMENT; PATENT; RESEARCH ETHICS; TRANSPLANTATION; UNITED STATES;

AIDS VACCINES; DEVELOPING COUNTRIES; ETHICS, RESEARCH; EUROPEAN UNION; FORECASTING; HUMANS; INFORMED CONSENT; INTELLECTUAL PROPERTY; OWNERSHIP; POLICY MAKING; TISSUE AND ORGAN PROCUREMENT; UNITED STATES;

EID: 40649089222     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2006.019612     Document Type: Article

References (72)

1. For such a focus, see for example Björkman B, Hansson SO. Bodily rights and property rights. J Med Ethics 2006; 32:209-14.
2. Goodson ML, Vernon BG. A study of public opinion on the use of tissue samples from living subjects for clinical research. J Clin Path 2004;57:135-8.
3. Start RD, Brown W, Bryant RJ, et al. Ownership and uses of human tissue: Does the Nuffield bioethics report accord with opinion of surgical inpatients? Br Med J 1996;313:1366-8.
4. Chen DT, Rosenstein DL, Muthappan P, et al. Research with stored biological samples: what do research participants want? Arch Intern Med 2005;165:652-5.
5. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. A follow up discussion paper. London: March 2005:62 It is noted in the discussion paper, with regard to large scale studies in genetic epidemiology that are currently being conducted in several different populations, that there are a number of complex interacting factors involved such as the relationship between intellectual property protection and the ownership and the rights pertaining to the resources on which the intellectual property has been based.
6. World Health Organization. Public health innovation and intellectual property rights. Report of the Commission on intellectual property rights, innovation and public health, April 2006.
7. Godard B, Schmidtke J, Cassiman JJ, et al. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Eur J Hum Genet 2003; 11(suppl 2): S88-S122.
8. National Bioethics Advisory Commission (NBAC). Research Involving human biological materials: ethical issues and policy guidance. Rockville, MD: August 1999.
9. Charo RA. Body of Research- Ownership and use of Human Tissue. New Engl J Med 2006; 355:1517-19.
10. See reference 9, p. 1518 and Protection of Human Subjects, 45 CFR. Public Welfare, pt. 46 (2006).
11. Joint United Nations Programme on HIV/AIDS (UNAIDS)/World Health Organisation (WHO). AIDS epidemic update: special report on HIV prevention. Geneva: December 2005:16.
12. Other challenges that are mentioned in the report are inadequate resources, clinical trial and regulatory concerns. UNAIDS/WHO (See reference 11, p. 16).
13. AVAC AIDS Vaccines at the Crossroads, (September 2005), http:// www.avac.org/pdf/reports/2005_Chapter4.pdf (accessed 20 Dec 2007)
14. See reference 13, p34.
15. Coordinating Committee of the Global HIV/AIDS Vaccine Enterprise. The Global HIV/AIDS Enterprise: scientific strategic plan. Plos Medicine 2005;2:111-17.
16. Andanda P. A golden chance for medical ethics in Kenya. Science and Development Network (June 2004), http://www.scidev.net/Opionions/ index.cfm?fuseaction = readOpinions&itemid = 283&languages = 1.
17. Butler D. Scientists deny ethical breach at Kenyan orphanage. Nature 2004;49:491.
18. Renowned Nairobi Orphanage in suspect study Daily Nation (2002), http://www.nationaudio.com/News/DailyNation/Supplements/horizon/ 25102001/story1.htm (accessed 20 Dec 2007)
19. Nuffield Council on Bioethics. Human Tissue: Ethical and Legal Issues. April 1995:96.
20. Bently L, Sherman B. The Ethics of Patenting: Towards a Transgenic Patent System. Med Law Rev 1995;3:275-91.
21. Grubb A. The Nuffield Council Report on human tissue. Med Law Rev 1995;3:235-6.
22. See Bently L, Sherman B (reference 20), and Matthews P. The man of property. Med Law Rev 1995;3:251-74.
23. Weisman J. Organs as assets. Isr Law Rev 1993; 27:610-23.
24. Tavar R, Murphy TF. The Case for compensation of tissue donors. Arch Intern Med 2001;161:1924-5.
25. Ashburn TT, Conn G, Eisenstein BI, Mass B, in reply to Tavar R, Murphy TF (See reference 24).
26. Pottage A. The inscription of life in law: genes, patents and bio-politics. Mod Law Rev 1998;61:740-65.
27. Szarka E. Patenting in biotechnology: a review of the 20th symposium of ECB8 [the 8th European Congress on Biotechnology]. J Biotechnol 1999;67:1-11.
28. [1999] QB 521.
29. Dobson and Another v North Tyneside Health Authority and Another [1996] All England Law Reports 474. For a detailed analysis of the inconsistencies and loopholes that these contradictory judgments created, see Plomer A. The Law and Ethics of Medical Research: International Bioethics and Human Rights (London: Cavendish Publishing Limited, 2005), pp100-2.
30. Morenon EP, Nagged by NAGPRA: Is there an archeological ethic? In Fluehr-Lobban C. (ed.) Ethics and the Profession of Anthropology: Dialogue for Ethically Conscious Practice, Walnut Creek, CA: Almitra Press, 118.
31. Langat SK. Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya. Bioethics 2005; 19:537-49.
32. Wandler D, Pace C, Talisuna AO, et al. Research on stored biological samples: the views of Ugandans. IRB 2005;27:1-5.
33. Ministry of Health. Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, March 2005.
34. See reference 33, p.44.
35. International Declaration on Human Genetic Data. http:// portal.unesco.org/en/ev.php-URL_ID = 17720&URL_DO = DO_TOPIC&URL_SECTION = 201.html (accessed 20 Dec 2007) The uses of samples that are provided for under Article 5 are diagnosis and health care; medical and other scientific research; forensic medicine and legal proceedings and any other purposes that are consistent with the Universal Declaration on the Human Genome and Human rights and international law of human rights.
36. Patent law treaty, http://www.wipo.int/treaties/en/ip/plt/trtdocs wo038.html (accessed 20 Dec 2007).
37. Patent cooperation treaty, http://www.wipo.int/pct/en/texts/articles/ atoc.htm (accessed 20 Dec 2007).
38. Ng Siew EK. The impact of the international patent system on developing countries. A study commissioned by the World Intellectual Property Organisation's secretariat (July 2003), http://www.wipo.int/ documents/en/document/govbody/wo_gb_ab/doc/a_39_13add3.doc (accessed 20 Dec 2007).
39. Nderitu T. Balancing Pills and Patents: Intellectual Property and the HIV/AIDS Crisis. Murdoch University Electronic J of Law 2001; 8(3) http://www.murdoch.edu.au/elaw/issues/v8n3/nderitu83.html (accessed 20 Dec 2007).
40. European patent convention, http://www.european-patent-office.org/legal/ epc/e/ma1.html#CVN (accessed Dec 2007).
41. See reference 27. The Relaxin case concerned the patenting of genes isolated from pregnant women, which were encoded to produce Relaxin. The patent was granted to the Horward Florey Institute of Experimental Physiology and Medicine, of Melbourne Australia to cover the hormone relaxin, which relaxes the uterus during childbirth. The gene was obtained from a human ovary.
42. See reference 27. The notion of 'ordre public' includes the safeguarding of public security, the protection of the physical integrity of individuals and also the protection of the environment.
43. See reference 19, p.97.
44. Government of India, F. No.L. 19015/53/97-IH(Pt.) Ministry of Health & F.W. Department of Health, Nirman Bhawan, New Delhi (19th November 1997) Guidelines for Exchange of Human Biological Material for Biomedical Research Purposes. http://icmr.nic.in/min.htm (accessed 20 Dec 2007).
45. The human materials that are listed in Clause I of the guidelines are: Organs and parts of organs; Cells and tissue; Sub-cellular structures and cell products: Blood; Gametes (sperm and Ova); Embryos and Fetal Tissue; Wastes (urine, faeces, sweat, hair, epithelial scales, nail clippings, placenta etc.) and Cell lines from human tissues.
46. See paragraph II of the guidelines.
47. The standard material transfer agreement can be accessed at, http:/ icmr.nic.in/guide/mta.doc (accessed 6 Jan 08).
48. Jones GD, Gear R, Galvin AK. Stored human tissue: an ethical perspective on the fate of anonymous, archival material. J Med Ethics 2003;29:343-7.
49. National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance. Rockville: National Bioethics Advisory Commission, August 1999.
50. Mudur G. Indian scientists object to export of human biological material for research. Brit Med J 23 Jan 2006 http:// bmj.bmjjournals.com/cgi/content/full/325/7371/990/b (accessed 20 Dec 2007).
51. Matsotso P, Auton M, Banoo S, et al. How does the regulatory framework affect incentives for research development? Geneva CIPIH [Commission on Intellectual Property Rights, Innovation and Public Health] study paper, 2005:68.http://www.who.int/intellectualproperty/ studies/Study5.pdf (accessed 20 Dec 2007).
52. See reference 13, p35.
53. See reference 13, pp36-37.
54. Draft covenant not to sue is available at, http://www.avac.org/pdf/
55. Guenter D, Esparza J, Macklin R. Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). J Med Ethics 2000;26:37-43.
56. 793 P.2d 479, 481 (cal.1990).
57. Perley SN. From control over one's body to control over one's body parts: extending the doctrine of informed consent. New York University LR 1992;67:335-65.
58. Andanda P. International legal frameworks for benefit sharing with developing countries presentation at the Cape Town workshop on benefit sharing with developing countries, European Commission funded workshop within the Genomics and Benefit Sharing with developing countries, Cape Town, 5-6 May 2004.
59. van Diest PJ, Savulescu J. For and against: no consent should be needed for using leftover body material for scientific purposes. Brit Med J 2002;325:648-51.
60. Furness PN, Nicholson ML. Obtaining explicit consent for the use of archival tissue samples: practical issues. J Med Ethics 2004; 30:561-4.
61. US District Court, Eastern District of Missouri Eastern Division, Case No. 4:03 cv 01065 SNL. The judgment, which was handed down on 14th April 2006 is available at http://prostatecure.wustl.edu/pdf/ findingsOfFact.pdf (accessed 20 Dec 2007).
62. 45 C.F.R & 46.116(a) (8).
63. 264 F. Supp. 2d 1064 (S.D. Fla.2003) at 1075 6 1076.
64. Kaiser J. Court decides tissue samples belong to University, not patients. Science 2006;312:346.
65. Hoeyer K, Olofsson BO, Mjorndal T, et al. The ethics of research using biobanks: reasons to question the importance attributed to informed consent. Arch Intern Med 2005;165:97-100.
66. Ashburn TT, Wilson SK, Eisenstein BI. Human tissue research in the genomic era of medicine: balancing individual and societal interests. Arch Intern Med 2000;160:3377-84. Cited in Hoeyer K, et al see reference 65.
67. Marshall E. Families sue hospital, scientists for control of Canavan gene. Science online 2000;290:1062.
68. This position is in accordance with the UK Patents Act 1977, section 60(5).
69. The Royal College of Pathologists. Consensus statement of recommended policies for uses of human tissue in research, education and quality control. London, 1999.
70. Tedeschi G. Ownership of organs taken from a living person. Isr LR 1993;27:624-51.
71. US Congress, Office of Technology Assessment, New Developments in Biotechnology: Ownership of human tissues and cells- special report, OTA- BA-337 (Washington, DC: US Government printing Office, March 1987. http://govinfo.library.unt.edu/ota/ota_3/DATA/1987/8719.PDF (accessed 20 Dec 2007).
72. Murray TH. Congressional testimony, October 19 (1985).